A Single-center, 2-arm Interventional Study to Determine the Association between the Gut Microbiome and the Pharmacokinetic Profile of Palbociclib in Healthy Female Volunteers

BioCorteX Pty Ltd0 sites20 target enrollmentAugust 1, 2023

ConditionsCancer Cancer - Any cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cancer
Sponsor: BioCorteX Pty Ltd
Enrollment: 20
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 1, 2023

End Date

September 3, 2023

Last Updated

last year

Study Type

Interventional

Sex

Female

Investigators

Sponsor

BioCorteX Pty Ltd

Eligibility Criteria

Inclusion Criteria

•1\.Must have given written informed consent, before any study\-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
•2\.Healthy female, aged between 18 and 65 years, inclusive at screening.
•3\.Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
•4\.Participant is medically healthy (in the opinion of the PI), as determined by pre\-study medical history and without clinically significant abnormalities including:
•a.Physical examination without any additional clinically relevant findings
•b.Systolic blood pressure in the range of 90 to 140 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after 5 minutes in supine position.
•c.Heart rate in the range of 40 to 100 beats/minute after 5 minutes rest in supine position.
•d.Body temperature (tympanic), between 35\.5°C and 37\.7°C.
•e.Electrocardiogram (ECG) without clinically significant abnormal including QT interval corrected for Fredericia (QTcF) between 350 to 470 msec.
•Note: The above assessments may be repeated, if abnormal values were recorded in the first instance, at the discretion of the Investigator (or delegate).

Exclusion Criteria

•1\.Hypersensitivity or other clinically significant reaction to the study drug or its active ingredients.
•2\.History of any clinically significant disorder, including cardiovascular, hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue disease, uncontrolled endocrine/metabolic, oncologic (within the last 5 years), neurologic, and psychiatric diseases, or any disorder that may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug. Participants with fully resolved childhood asthma with no adult reoccurrence and participants who have undergone cholecystectomy may be included at the discretion of the PI.
•3\.Absolute neutrophil count \<2000 /mm3
•4\.Platelet count \< 150,000 /mm3
•5\.Antibiotic usage with 30 days prior to screening
•6\.Concurrent enrolment in another clinical study, or dosed in another clinical study within 30 days or 5 half\-lives (whichever is longer) prior to screening.
•7\.Regular consumption of \>14 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer \[4\.9% Alc/Vol], 100 mL wine \[12% Alc/Vol], 30 mL spirit \[40% Alc/Vol]).
•8\.Positive alcohol breath or urine test at Screening or upon admission to the clinic on Day \-1\.
•9\.Positive urine drugs of abuse test at Screening or upon admission to the clinic on Day \-1\.
•10\.Use of tobacco products or nicotine\-containing products (including smoking cessation aids such as gum or patches), within 30 days prior to screening, and/or a positive urine cotinine test at Screening or upon admission to the clinic on Day \-1\.